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Title 21

Food and Drugs

Part 1300 to End

Revised as of April 1, 2014

Containing a codification of documents

of general applicability and future effect

As of April 1, 2014

Published by the Office of the Federal Register

National Archives and Records Administration

as a Special Edition of the Federal Register

VerDate Mar2010 11:22 May 06, 2014 Jkt 232078 PO 00000 Frm 00001 Fmt 8091 Sfmt 8091 Y:\SGML\232078.XXX 232078

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U.S. GOVERNMENT OFFICIAL EDITION NOTICE

Legal Status and Use of Seals and Logos

The seal of the National Archives and Records Administration

(NARA) authenticates the Code of Federal Regulations (CFR) as

the official codification of Federal regulations established under

the Federal Register Act. Under the provisions of 44 U.S.C. 1507, the

contents of the CFR, a special edition of the Federal Register, shall

be judicially noticed. The CFR is prima facie evidence of the origi-

nal documents published in the Federal Register (44 U.S.C. 1510).

It is prohibited to use NARAs official seal and the stylized Code

of Federal Regulations logo on any republication of this material

without the express, written permission of the Archivist of the

United States or the Archivists designee. Any person using

NARAs official seals and logos in a manner inconsistent with the

provisions of 36 CFR part 1200 is subject to the penalties specified

in 18 U.S.C. 506, 701, and 1017.

Use of ISBN Prefix

This is the Official U.S. Government edition of this publication

and is herein identified to certify its authenticity. Use of the 016

ISBN prefix is for U.S. Government Printing Office Official Edi-

tions only. The Superintendent of Documents of the U.S. Govern-

ment Printing Office requests that any reprinted edition clearly be

labeled as a copy of the authentic work with a new ISBN.

U . S. G O VE R NM E NT P R IN T IN G O F FI C E

U.S. Superintendent of Documents Washington, DC 204020001

http://bookstore.gpo.gov

Phone: toll-free (866) 512-1800; DC area (202) 512-1800


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Table of ContentsPage

Explanation ................................................................................................ v

Title 21:

Chapter IIDrug Enforcement Administration, Department of

Justice ......................................................................................... 3

Chapter IIIOffice of National Drug Control Policy ...................... 245

Finding Aids:

Table of CFR Titles and Chapters ....................................................... 317

Alphabetical List of Agencies Appearing in the CFR ......................... 337

List of CFR Sections Affected ............................................................. 347


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Cite this Code: CFR

To cite the regulations in

this volume use title,part and section num-

ber. Thus, 21 CFR1300.01 refers to title 21,part 1300, section 01.


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Explanation

The Code of Federal Regulations is a codification of the general and permanent

rules published in the Federal Register by the Executive departments and agen-

cies of the Federal Government. The Code is divided into 50 titles which represent

broad areas subject to Federal regulation. Each title is divided into chapters

which usually bear the name of the issuing agency. Each chapter is further sub-divided into parts covering specific regulatory areas.

Each volume of the Code is revised at least once each calendar year and issued

on a quarterly basis approximately as follows:

Title 1 through Title 16..............................................................as of January 1

Title 17 through Title 27 .................................................................as of April 1

Title 28 through Title 41 ..................................................................as of July 1

Title 42 through Title 50 .............................................................as of October 1

The appropriate revision date is printed on the cover of each volume.

LEGAL STATUS

The contents of the Federal Register are required to be judicially noticed (44

U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text

of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

The Code of Federal Regulations is kept up to date by the individual issues

of the Federal Register. These two publications must be used together to deter-

mine the latest version of any given rule.

To determine whether a Code volume has been amended since its revision date

(in this case, April 1, 2014), consult the List of CFR Sections Affected (LSA),

which is issued monthly, and the Cumulative List of Parts Affected, which

appears in the Reader Aids section of the daily Federal Register. These two lists

will identify the Federal Register page number of the latest amendment of any

given rule.

EFFECTIVE AND EXPIRATION DATES

Each volume of the Code contains amendments published in the Federal Reg-

ister since the last revision of that volume of the Code. Source citations for

the regulations are referred to by volume number and page number of the Federal

Register and date of publication. Publication dates and effective dates are usu-

ally not the same and care must be exercised by the user in determining the

actual effective date. In instances where the effective date is beyond the cut-

off date for the Code a note has been inserted to reflect the future effective

date. In those instances where a regulation published in the Federal Register

states a date certain for expiration, an appropriate note will be inserted following

the text.

OMB CONTROL NUMBERS

The Paperwork Reduction Act of 1980 (Pub. L. 96511) requires Federal agencies

to display an OMB control number with their information collection request.


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vi

Many agencies have begun publishing numerous OMB control numbers as amend-

ments to existing regulations in the CFR. These OMB numbers are placed as

close as possible to the applicable recordkeeping or reporting requirements.

PAST PROVISIONS OF THE CODE

Provisions of the Code that are no longer in force and effect as of the revision

date stated on the cover of each volume are not carried. Code users may find

the text of provisions in effect on any given date in the past by using the appro-

priate List of CFR Sections Affected (LSA). For the convenience of the reader,

a List of CFR Sections Affected is published at the end of each CFR volume.

For changes to the Code prior to the LSA listings at the end of the volume,

consult previous annual editions of the LSA. For changes to the Code prior to

2001, consult the List of CFR Sections Affected compilations, published for 1949-

1963, 1964-1972, 1973-1985, and 1986-2000.

[RESERVED] TERMINOLOGY

The term [Reserved] is used as a place holder within the Code of Federal

Regulations. An agency may add regulatory information at a [Reserved] loca-

tion at any time. Occasionally [Reserved] is used editorially to indicate that

a portion of the CFR was left vacant and not accidentally dropped due to a print-

ing or computer error.

INCORPORATION BY REFERENCE

What is incorporation by reference? Incorporation by reference was established

by statute and allows Federal agencies to meet the requirement to publish regu-

lations in the Federal Register by referring to materials already published else-

where. For an incorporation to be valid, the Director of the Federal Register

must approve it. The legal effect of incorporation by reference is that the mate-

rial is treated as if it were published in full in the Federal Register (5 U.S.C.

552(a)). This material, like any other properly issued regulation, has the force

of law.

What is a proper incorporation by reference? The Director of the Federal Register

will approve an incorporation by reference only when the requirements of 1 CFR

part 51 are met. Some of the elements on which approval is based are:

(a) The incorporation will substantially reduce the volume of material pub-

lished in the Federal Register.

(b) The matter incorporated is in fact available to the extent necessary to

afford fairness and uniformity in the administrative process.

(c) The incorporating document is drafted and submitted for publication in

accordance with 1 CFR part 51.

What if the material incorporated by reference cannot be found? If you have any

problem locating or obtaining a copy of material listed as an approved incorpora-

tion by reference, please contact the agency that issued the regulation containing

that incorporation. If, after contacting the agency, you find the material is not

available, please notify the Director of the Federal Register, National Archives

and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001, or

call 202-741-6010.

CFR INDEXES AND TABULAR GUIDES

A subject index to the Code of Federal Regulations is contained in a separate

volume, revised annually as of January 1, entitled CFR I NDEX AND FINDING AIDS.

This volume contains the Parallel Table of Authorities and Rules. A list of CFR

titles, chapters, subchapters, and parts and an alphabetical list of agencies pub-

lishing in the CFR are also included in this volume.


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THIS TITLE

Title 21FOOD AND DRUGS is composed of nine volumes. The parts in these

volumes are arranged in the following order: Parts 199, 100169, 170199, 200299,

300499, 500599, 600799, 8001299 and 1300 to end. The first eight volumes, con-

taining parts 11299, comprise Chapter IFood and Drug Administration, Depart-

ment of Health and Human Services. The ninth volume, containing part 1300 toend, includes Chapter IIDrug Enforcement Administration, Department of Jus-

tice, and Chapter IIIOffice of National Drug Control Policy. The contents of

these volumes represent all current regulations codified under this title of the

CFR as of April 1, 2014.

For this volume, Michele Bugenhagen was Chief Editor. The Code of Federal

Regulations publication program is under the direction of the Managing Editor,

assisted by Ann Worley.


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Title 21Food and Drugs(This book contains part 1300 to End)

Part

CHAPTER IIDrug Enforcement Administration, Depart-ment of Justice .................................................................. 1301

CHAPTER IIIOffice of National Drug Control Policy ............ 1401


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CHAPTER IIDRUG ENFORCEMENT

ADMINISTRATION, DEPARTMENT OF JUSTICE

Part Page

1300 Definitions .............................................................. 51301 Registration of manufacturers, distributors, and

dispensers of controlled substances ..................... 211302 Labeling and packaging requirements for con-

trolled substances ................................................ 541303 Quotas ..................................................................... 561304 Records and reports of registrants .......................... 641305 Orders for schedule I and II controlled substances 821306 Prescriptions ........................................................... 901307 Miscellaneous .......................................................... 1021308 Schedules of controlled substances ......................... 1051309 Registration of manufacturers, distributors, im-

porters and exporters of list I chemicals .............. 1291310 Records and reports of listed chemicals and certainmachines .............................................................. 140

1311 Requirements for electronic orders and prescrip-tions ..................................................................... 164

1312 Importation and exportation of controlled sub-stances ................................................................. 185

1313 Importation and exportation of list I and list IIchemicals ............................................................. 199

1314 Retail sale of scheduled listed chemical products ... 2101315 Importation and production quotas for ephedrine,

pseudoephedrine, and phenylpropanolamine ........ 2181316 Administrative functions, practices, and proce-

dures ..................................................................... 228

1321 DEA Mailing addresses ............................................ 24113221399 [Reserved]


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PART 1300DEFINITIONS

Sec.1300.01 Definitions relating to controlled

substances.1300.02 Definitions relating to listed chemi-

cals.1300.03 Definitions relating to electronic or-

ders for controlled substances and elec-tronic prescriptions for controlled sub-stances.

1300.04 Definitions relating to the dis-pensing of controlled substances bymeans of the Internet.

AUTHORITY: 21 U.S.C. 802, 821, 829, 871(b),

951, 958(f).

SOURCE: 62 FR 13941, Mar. 24, 1997, unlessotherwise noted.

1300.01 Definitions relating to con-trolled substances.

(a) Any term not defined in this partshall have the definition set forth insection 102 of the Act (21 U.S.C. 802),except that certain terms used in part1316 of this chapter are defined at thebeginning of each subpart of that part.

(b) As used in parts 1301 through 1308and part 1312 of this chapter, the fol-lowing terms shall have the meaningsspecified:

Act means the Controlled Substances

Act, as amended (84 Stat. 1242; 21 U.S.C.801) and/or the Controlled SubstancesImport and Export Act, as amended (84Stat. 1285; 21 U.S.C. 951).

Administration means the Drug En-forcement Administration.

Administrator means the Adminis-trator of the Drug Enforcement Admin-istration. The Administrator has beendelegated authority under the Act bythe Attorney General (28 CFR 0.100).

Anabolic steroid means any drug orhormonal substance, chemically andpharmacologically related to testos-terone (other than estrogens,progestins, corticosteroids, anddehydroepiandrosterone), and includes:

(1) 3b,17-dihydroxy-5a-androstane(2) 3a,17b-dihydroxy-5a-androstane(3) 5a-androstan-3,17-dione(4) 1-androstenediol (3b,17b-dihydroxy-

5a-androst-1-ene)(5) 1-androstenediol (3a,17b-dihydroxy-

5a-androst-1-ene)(6) 4-androstenediol (3b,17b-dihydroxy-

androst-4-ene)(7) 5-androstenediol (3b,17b-dihydroxy-

androst-5-ene)

(8) 1-androstenedione ([5a]-androst-1-en-3,17-dione)

(9) 4-androstenedione (androst-4-en-3,17-dione)

(10) 5-androstenedione (androst-5-en-3,17-dione)

(11) bolasterone (7a,17a-dimethyl-17b-hydroxyandrost-4-en-3-one)

(12) boldenone (17b-hydroxyandrost-1,4-diene-3-one)

(13) boldione (androsta-1,4-diene-3,17-dione)

(14) calusterone (7b,17a-dimethyl-17b-hydroxyandrost-4-en-3-one)

(15) clostebol (4-chloro-17b-hydroxyandrost-4-en-3-one)

(16) dehydrochloromethyltestosterone(4-chloro-17b-hydroxy-17a-methyl-androst-1,4-dien-3-one)

(17) desoxymethyltestosterone (17a-methyl-5a-androst-2-en-17b-ol)(a.k.a. madol)

(18) D1-dihydrotestosterone (a.k.a.1-testosterone) (17b-hydroxy-5a-androst-1-en-3-one)

(19) 4-dihydrotestosterone (17b-hy-droxy-androstan-3-one)

(20) drostanolone (17b-hydroxy-2a-methyl-5a-androstan-3-one)

(21) ethylestrenol (17a-ethyl-17b-hydroxyestr-4-ene)

(22) fluoxymesterone (9-fluoro-17a-methyl-11b,17b-dihydroxyandrost-4-en-3-one)

(23) formebolone (2-formyl-17a-methyl-11a,17b-dihydroxyandrost-1,4-dien-3-one)

(24) furazabol (17a-methyl-17b-hydroxyandrostano[2,3-c]-furazan)

(25) 13b-ethyl-17b-hydroxygon-4-en-3-one

(26) 4-hydroxytestosterone (4,17b-dihydroxy-androst-4-en-3-one)

(27) 4-hydroxy-19-nortestosterone(4,17b-dihydroxy-estr-4-en-3-one)

(28) mestanolone (17a-methyl-17b-hy-droxy-5-androstan-3-one)

(29) mesterolone (1a-methyl-17b-hy-

droxy-[5a]-androstan-3-one)(30) methandienone (17a-methyl-17b-

hydroxyandrost-1,4-dien-3-one)(31) methandriol (17a-methyl-3b,17b-

dihydroxyandrost-5-ene)(32) Methasterone (2a,17a-dimethyl-5a-

androstan-17b-ol-3-one)(33) methenolone (1-methyl-17b-hy-

droxy-5a-androst-1-en-3-one)(34) 17a-methyl-3b,17b-dihydroxy-5a-an-

drostane


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(35) 17a-methyl-3a,17b-dihydroxy-5a-an-drostane

(36) 17a-methyl-3b,17b-dihydroxyandrost-4-ene

(37) 17a-methyl-4-hydroxynandrolone(17a-methyl-4-hydroxy-17b-hydroxyestr-4-en-3-one)

(38) methyldienolone (17a-methyl-17b-hydroxyestra-4,9(10)-dien-3-one)

(39) methyltrienolone (17a-methyl-17b-hydroxyestra-4,9,11-trien-3-one)

(40) methyltestosterone (17a-methyl-17b-hydroxyandrost-4-en-3-one)

(41) mibolerone (7a,17a-dimethyl-17b-hydroxyestr-4-en-3-one)(42) 17a-methyl-D1-dihydrotestosterone

(17b-hydroxy-17a-methyl-5a-androst-1-en-3-one) (a.k.a. 17-a-methyl-1-testosterone)

(43) nandrolone (17b-hydroxyestr-4-en-3-one)

(44) 19-nor-4-androstenediol (3b, 17b-dihydroxyestr-4-ene)

(45) 19-nor-4-androstenediol (3a, 17b-dihydroxyestr-4-ene)

(46) 19-nor-5-androstenediol (3b, 17b-dihydroxyestr-5-ene)

(47) 19-nor-5-androstenediol (3a, 17b-dihydroxyestr-5-ene)

(48) 19-nor-4,9(10)-androstadienedione

(estra-4,9(10)-diene-3,17-dione)(49) 19-nor-4-androstenedione (estr-4-en-

3,17-dione)

(50) 19-nor-5-androstenedione (estr-5-en-3,17-dione)

(51) norbolethone (13b, 17a-diethyl-17b-hydroxygon-4-en-3-one)

(52) norclostebol (4-chloro-17b-hydroxyestr-4-en-3-one)

(53) norethandrolone (17a-ethyl-17b-hydroxyestr-4-en-3-one)

(54) normethandrolone (17a-methyl-17b-hydroxyestr-4-en-3-one)

(55) oxandrolone (17a-methyl-17b-hy-droxy-2-oxa-[5a]-androstan-3-one)

(56) oxymesterone (17a-methyl-4,17b-

dihydroxyandrost-4-en-3-one)(57) oxymetholone (17a-methyl-2-

hydroxymethylene-17b-hydroxy-[5a]-androstan-3-one)

(58) Prostanozol (17b-hydroxy-5a-androstano[3,2-c]pyrazole)

(59) stanozolol (17a-methyl-17b-hy-droxy-[5a]-androst-2-eno[3,2-c]-pyr-azole)

(60) stenbolone (17b-hydroxy-2-methyl-[5a]-androst-1-en-3-one)

(61) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oicacid lactone)

(62) testosterone (17b-hydroxyandrost-4-en-3-one)

(63) tetrahydrogestrinone (13b, 17a-diethyl-17b-hydroxygon-4,9,11-trien-3-one)

(64) trenbolone (17b-hydroxyestr-4,9,11-trien-3-one)

(65) Any salt, ester, or ether of a drugor substance described in this para-graph. Except such term does notinclude an anabolic steroid that is

expressly intended for administra-tion through implants to cattle orother nonhuman species and thathas been approved by the Secretaryof Health and Human Services forsuch administration. If any personprescribes, dispenses, or distributessuch steroid for human use, theperson shall be considered to haveprescribed, dispensed, or distrib-uted an anabolic steroid within themeaning of this paragraph.

Automated dispensing system means amechanical system that performs oper-ations or activities, other thancompounding or administration, rel-ative to the storage, packaging, count-

ing, labeling, and dispensing of medica-tions, and which collects, controls, andmaintains all transaction information.

Basic class means, as to controlledsubstances listed in Schedules I and II:

(1) Each of the opiates, including itsisomers, esters, ethers, salts, and saltsof isomers, esters, and ethers wheneverthe existence of such isomers, esters,ethers, and salts is possible within thespecific chemical designation, listed in 1308.11(b) of this chapter;

(2) Each of the opium derivatives, in-cluding its salts, isomers, and salts ofisomers whenever the existence of suchsalts, isomers, and salts of isomers ispossible within the specific chemical

designation, listed in 1308.11(c) of thischapter;

(3) Each of the hallucinogenic sub-stances, including its salts, isomers,and salts of isomers whenever the ex-istence of such salts, isomers, and saltsof isomers is possible within the spe-cific chemical designation, listed in 1308.11(d) of this chapter;

(4) Each of the following substances,whether produced directly or indirectly


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such article from the jurisdiction ofthe United States (whether or not suchtaking out or removal constitutes anexportation within the meaning of thecustoms and related laws of the UnitedStates).

Exporter includes every person whoexports, or who acts as an exportbroker for exportation of, controlledsubstances listed in any schedule.

Freight forwarding facility means aseparate facility operated by a distrib-uting registrant through which sealed,packaged controlled substances in un-

marked shipping containers (i.e., thecontainers do not indicate that thecontents include controlled substances)are, in the course of delivery to, or re-turn from, customers, transferred inless than 24 hours. A distributing reg-istrant who operates a freight for-warding facility may use the facility totransfer controlled substances fromany location the distributing reg-istrant operates that is registered withthe Administration to manufacture,distribute, or import controlled sub-stances, or, with respect to returns,registered to dispense controlled sub-stances, provided that the notice re-quired by 1301.12(b)(4) of Part 1301 of

this chapter has been submitted andapproved. For purposes of this defini-tion, a distributing registrant is aperson who is registered with the Ad-ministration as a manufacturer, dis-tributor, and/or importer.

Hearing means:(1) In part 1301 of this chapter, any

hearing held for the granting, denial,revocation, or suspension of a registra-tion pursuant to sections 303, 304, and1008 of the Act (21 U.S.C. 823, 824 and958).

(2) In part 1303 of this chapter, anyhearing held regarding the determina-tion of aggregate production quota orthe issuance, adjustment, suspension,

or denial of a procurement quota or anindividual manufacturing quota.

(3) In part 1308 of this chapter, anyhearing held for the issuance, amend-ment, or repeal of any rule issuablepursuant to section 201 of the Act (21U.S.C. 811).

Import means, with respect to any ar-ticle, any bringing in or introductionof such article into either the jurisdic-tion of the United States or the cus-

toms territory of the United States,and from the jurisdiction of the UnitedStates into the customs territory ofthe United States (whether or not suchbringing in or introduction constitutesan importation within the meaning ofthe tariff laws of the United States).

Importer includes every person whoimports, or who acts as an importbroker for importation of, controlledsubstances listed in any schedule.

Individual practitioner means a physi-cian, dentist, veterinarian, or other in-dividual licensed, registered, or other-

wise permitted, by the United States orthe jurisdiction in which he/she prac-tices, to dispense a controlled sub-stance in the course of professionalpractice, but does not include a phar-macist, a pharmacy, or an institutionalpractitioner.

Institutional practitioner means a hos-pital or other person (other than an in-dividual) licensed, registered, or other-wise permitted, by the United States orthe jurisdiction in which it practices,to dispense a controlled substance inthe course of professional practice, butdoes not include a pharmacy.

Interested person means any personadversely affected or aggrieved by any

rule or proposed rule issuable pursuantto section 201 of the Act (21 U.S.C. 811).

Inventory means all factory andbranch stocks in finished form of abasic class of controlled substancemanufactured or otherwise acquired bya registrant, whether in bulk, commer-cial containers, or contained in phar-maceutical preparations in the posses-sion of the registrant (including stocksheld by the registrant under separateregistration as a manufacturer, im-porter, exporter, or distributor).

Isomer means:(1) The optical isomer, except as used

in 1308.11(d) and 1308.12(b)(4) of thischapter. As used in 1308.11(d) of this

chapter, the term isomer means anyoptical, positional, or geometric iso-mer. As used in 1308.12(b)(4) of thischapter, the term isomer means anyoptical or geometric isomer;

(2) As used in 1308.11(d) of this chap-ter, the term positional isomermeans any substance possessing thesame molecular formula and corestructure and having the same func-tional group(s) and/or substituent(s) as


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Drug Enforcement Administration, Justice 1300.01

those found in the respective ScheduleI hallucinogen, attached at any posi-tion(s) on the core structure, but insuch manner that no new chemicalfunctionalities are created and no ex-isting chemical functionalities are de-stroyed relative to the respectiveSchedule I hallucinogen. Rearrange-ments of alkyl moieties within or be-tween functional group(s) or substit-uent(s), or divisions or combinations ofalkyl moieties, that do not create newchemical functionalities or destroy ex-isting chemical functionalities, are al-

lowed i.e., result in compounds whichare positional isomers. For purposes ofthis definition, the core structure isthe parent molecule that is the com-mon basis for the class; for example,tryptamine, phenethylamine, orergoline. Examples of rearrangementsresulting in creation and/or destructionof chemical functionalities (and there-fore resulting in compounds which arenot positional isomers) include, but arenot limited to: Ethoxy to alpha-hy-droxyethyl, hydroxy and methyl tomethoxy, or the repositioning of a phe-nolic or alcoholic hydroxy group tocreate a hydroxyamine. Examples ofrearrangements resulting in com-pounds which would be positional iso-mers include: Tert-butyl to sec-butyl,methoxy and ethyl to isopropoxy, N,N-diethyl to N-methyl-N-propyl, or alpha-methylamino to N-methylamino.

Jurisdiction of the United States meansthe customs territory of the UnitedStates, the Virgin Islands, the CanalZone, Guam, American Samoa, and theTrust Territories of the Pacific Islands.

Label means any display of written,printed, or graphic matter placed uponthe commercial container of any con-trolled substance by any manufacturerof such substance.

Labeling means all labels and other

written, printed, or graphic matter:(1) Upon any controlled substance or

any of its commercial containers orwrappers, or

(2) Accompanying such controlledsubstance.

Long Term Care Facility (LTCF) meansa nursing home, retirement care, men-tal care or other facility or institutionwhich provides extended health care toresident patients.

Maintenance treatment means the dis-pensing for a period in excess of twen-ty-one days, of a narcotic drug or nar-cotic drugs in the treatment of an indi-vidual for dependence upon heroin orother morphine-like drug.

Manufacture means the producing,preparation, propagation,compounding, or processing of a drugor other substance or the packaging orrepackaging of such substance, or thelabeling or relabeling of the commer-cial container of such substance, butdoes not include the activities of a

practitioner who, as an incident to his/her administration or dispensing suchsubstance in the course of his/her pro-fessional practice, prepares, com-pounds, packages or labels such sub-stance.

Manufacturer means a person whomanufactures a drug or other sub-stance, whether under a registration asa manufacturer or under authority ofregistration as a researcher or chem-ical analyst.

Mid-level practitioner means an indi-vidual practitioner, other than a physi-cian, dentist, veterinarian, or podia-trist, who is licensed, registered, orotherwise permitted by the United

States or the jurisdiction in which he/she practices, to dispense a controlledsubstance in the course of professionalpractice. Examples of mid-level practi-tioners include, but are not limited to,health care providers such as nursepractitioners, nurse midwives, nurseanesthetists, clinical nurse specialistsand physician assistants who are au-thorized to dispense controlled sub-stances by the State in which theypractice.

Name means the official name, com-mon or usual name, chemical name, orbrand name of a substance.

Narcotic drug means any of the fol-lowing whether produced directly or in-

directly by extraction from substancesof vegetable origin or independently bymeans of chemical synthesis or by acombination of extraction and chem-ical synthesis:

(1) Opium, opiates, derivatives ofopium and opiates, including their iso-mers, esters, ethers, salts, and salts ofisomers, esters, and ethers wheneverthe existence of such isomers, esters,ethers and salts is possible within the


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21 CFR Ch. II (4114 Edition) 1300.01

specific chemical designation. Suchterm does not include the isoquinolinealkaloids of opium.

(2) Poppy straw and concentrate ofpoppy straw.

(3) Coca leaves, except coca leavesand extracts of coca leaves from whichcocaine, ecgonine and derivatives of ec-gonine or their salts have been re-moved.

(4) Cocaine, its salts, optical and geo-metric isomers, and salts of isomers.

(5) Ecgonine, its derivatives, their

salts, isomers and salts of isomers.(6) Any compound, mixture, or prepa-ration which contains any quantity ofany of the substances referred to inparagraphs (1) through (5) of this defi-nition.

Narcotic treatment program means aprogram engaged in maintenance and/or detoxification treatment with nar-cotic drugs.

Net disposal means, for a stated pe-riod, the quantity of a basic class ofcontrolled substance distributed by theregistrant to another person, plus thequantity of that basic class used by theregistrant in the production of (or con-verted by the registrant into) another

basic class of controlled substance or anoncontrolled substance, plus thequantity of that basic class otherwisedisposed of by the registrant, less thequantity of that basic class returned tothe registrant by any purchaser, andless the quantity of that basic classdistributed by the registrant to an-other registered manufacturer of thatbasic class for purposes other than usein the production of, or conversioninto, another basic class of controlledsubstance or a noncontrolled substanceor in the manufacture of dosage formsof that basic class.

Person includes any individual, cor-poration, government or governmental

subdivision or agency, business trust,partnership, association, or other legalentity.

Pharmacist means any pharmacist li-censed by a State to dispense con-trolled substances, and shall includeany other person (e.g., pharmacist in-tern) authorized by a State to dispensecontrolled substances under the super-vision of a pharmacist licensed by suchState.

Prescription means an order for medi-

cation which is dispensed to or for an

ultimate user but does not include an

order for medication which is dispensed

for immediate administration to the

ultimate user (e.g., an order to dis-

pense a drug to a bed patient for imme-

diate administration in a hospital is

not a prescription).

Proceeding means all actions taken

for the issuance, amendment, or repeal

of any rule issued pursuant to section

201 of the Act (21 U.S.C. 811), com-

mencing with the publication by theAdministrator of the proposed rule,

amended rule, or repeal in the FEDERAL

REGISTER.

Purchaser means any registered per-

son entitled to obtain and execute

order forms pursuant to 1305.04 and

1305.06.

Readily retrievable means that certain

records are kept by automatic data

processing systems or other electronic

or mechanized recordkeeping systems

in such a manner that they can be sep-

arated out from all other records in a

reasonable time and/or records are kept

on which certain items are asterisked,

redlined, or in some other manner vis-ually identifiable apart from other

items appearing on the records.

Register and registration refer only to

registration required and permitted by

sections 303 or 1007 of the Act (21 U.S.C.

823 or 957).

Registrant means any person who is

registered pursuant to either section

303 or section 1008 of the Act (21 U.S.C.

823 or 958).

Reverse distributor means a registrant

who receives controlled substances ac-

quired from another DEA registrant for

the purpose of

(1) Returning unwanted, unusable, or

outdated controlled substances to the

manufacturer or the manufacturers

agent; or

(2) Where necessary, processing such

substances or arranging for processing

such substances for disposal.


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Supplier means any registered personentitled to fill order forms pursuant to 1305.06 of this chapter.

[62 FR 13941, Mar. 24, 1997, as amended at 65FR 44678, July 19, 2000; 68 FR 37409, June 24,2003; 68 FR 41228, July 11, 2003; 70 FR 25465,May 13, 2005; 70 FR 74656, Dec. 16, 2005; 71 FR60427, Oct. 13, 2006; 72 FR 67852, Dec. 3, 2007;74 FR 63609, Dec. 4, 2009; 77 FR 4230, Jan. 27,2012; 77 FR 44461, July 30, 2012]

1300.02 Definitions relating to listedchemicals.

(a) Any term not defined in this part

shall have the definition set forth insection 102 of the Act (21 U.S.C. 802),except that certain terms used in part1316 of this chapter are defined at thebeginning of each subpart of that part.

(b) As used in parts 1309, 1310, and1313 of this chapter, the followingterms shall have the meaning specified:

Act means the Controlled SubstancesAct, as amended (84 Stat. 1242; 21 U.S.C.801) and/or the Controlled SubstancesImport and Export Act, as amended (84Stat. 1285; 21 U.S.C. 951).

Administration means the Drug En-forcement Administration.

Administrator means the Adminis-trator of the Drug Enforcement Admin-

istration. The Administrator has beendelegated authority under the Act bythe Attorney General (28 CFR 0.100).

At retail, with respect to the sale orpurchase of a scheduled listed chemicalproduct, means a sale or purchase forpersonal use, respectively.

Broker and trader mean any indi-vidual, corporation, corporate division,partnership, association, or other legalentity which assists in arranging aninternational transaction in a listedchemical by

(1) Negotiating contracts;(2) Serving as an agent or inter-

mediary; or(3) Fulfilling a formal obligation to

complete the transaction by bringingtogether a buyer and seller, a buyerand transporter, or a seller and trans-porter, or by receiving any form ofcompensation for so doing.

Chemical export means transferringownership or control, or the sending ortaking of threshold quantities of listedchemicals out of the United States(whether or not such sending or takingout constitutes an exportation within

the meaning of the customs and relatedlaws of the United States).

Chemical exporter is a regulated per-son who, as the principal party in in-terest in the export transaction, hasthe power and responsibility for deter-mining and controlling the sending ofthe listed chemical out of the UnitedStates.

Chemical import means with respectto a listed chemical, any bringing in orintroduction of such listed chemicalinto either the jurisdiction of theUnited States or into the customs ter-

ritory of the United States (whether ornot such bringing in or introductionconstitutes an importation within themeaning of the tariff laws of theUnited States).

Chemical importer is a regulated per-son who, as the principal party in in-terest in the import transaction, hasthe power and responsibility for deter-mining and controlling the bringing inor introduction of the listed chemicalinto the United States.

Chemical mixture means a combina-tion of two or more chemical sub-stances, at least one of which is not alisted chemical, except that such termdoes not include any combination of a

listed chemical with another chemicalthat is present solely as an impurity orwhich has been created to evade the re-quirements of the Act.

Combination ephedrine product meansa drug product containing ephedrine orits salts, optical isomers, or salts of op-tical isomers, and therapeutically sig-nificant quantities of another activemedicinal ingredient.

Customs territory of the United Statesmeans the several States, the Districtof Columbia, and Puerto Rico.

Drug product means an active ingre-dient in dosage form that has been ap-proved or otherwise may be lawfullymarketed under the Federal Food,

Drug, and Cosmetic Act for distribu-tion in the United States.

Encapsulating machine means anymanual, semi-automatic, or fully auto-matic equipment which may be used tofill shells or capsules with any pow-dered, granular, semi-solid, or liquidmaterial.

Established business relationship meansthe regulated person has imported orexported a listed chemical at least


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21 CFR Ch. II (4114 Edition) 1300.02

once within the past six months, ortwice within the past twelve monthsfrom or to a foreign manufacturer, dis-tributor, or end user of the chemicalthat has an established business with afixed street address. A person or busi-ness that functions as a broker orintermediary is not a customer for pur-poses of this definition.

Established record as an importermeans that the regulated person hasimported a listed chemical at leastonce within the past six months, ortwice within the past twelve monthsfrom a foreign supplier.

Hearing means any hearing held forthe granting, denial, revocation, orsuspension of a registration pursuantto sections 303, 304, and 1008 of the Act(21 U.S.C. 823, 824 and 958).

International transaction means atransaction involving the shipment ofa listed chemical across an inter-national border (other than a UnitedStates border) in which a broker ortrader located in the United Statesparticipates.

Jurisdiction of the United States meansthe customs territory of the UnitedStates, the Virgin Islands, the Canal

Zone, Guam, American Samoa, and theTrust Territories of the Pacific Islands.

Listed chemical means any List Ichemical or List II chemical.

List I chemical means a chemical spe-cifically designated by the Adminis-trator in 1310.02(a) of this chapterthat, in addition to legitimate uses, isused in manufacturing a controlledsubstance in violation of the Act and isimportant to the manufacture of a con-trolled substance.

List II chemical means a chemical,other than a List I chemical, specifi-cally designated by the Administratorin 1310.02(b) of this chapter that, inaddition to legitimate uses, is used in

manufacturing a controlled substancein violation of the Act.

Mobile retail vendor means a person orentity that makes sales at retail froma stand that is intended to be tem-porary or is capable of being movedfrom one location to another, whetherthe stand is located within or on thepremises of a fixed facility (such as akiosk at a shopping center or an air-port) or whether the stand is located

on unimproved real estate (such as alot or field leased for retail purposes).

Name means the official name, com-mon or usual name, chemical name, orbrand name of a substance.

Person includes any individual, cor-poration, government or governmentalsubdivision or agency, business trust,partnership, association, or other legalentity.

Readily retrievable means that certainrecords are kept by automatic dataprocessing systems or other electronicor mechanized recordkeeping systems

in such a manner that they can be sep-arated out from all other records in areasonable time and/or records are kepton which certain items are asterisked,redlined, or in some other manner vis-ually identifiable apart from otheritems appearing on the records.

Register and registration refer only toregistration required and permitted bysections 303 or 1007 of the Act (21 U.S.C.823 or 957).

Registrant means any person who isregistered pursuant to either section303 or section 1008 of the Act (21 U.S.C.823 or 958).

Regular customer means a person withwhom the regulated person has an es-

tablished business relationship for aspecified listed chemical or chemicalsthat has been reported to the Adminis-tration subject to the criteria estab-lished in part 1313 of this chapter.

Regular importer means, with respectto a listed chemical, a person that hasan established record as an importer ofthat listed chemical that is reported tothe Administrator.

Regulated person means any indi-vidual, corporation, partnership, asso-ciation, or other legal entity who man-ufactures, distributes, imports, or ex-ports a listed chemical, a tableting ma-chine, or an encapsulating machine, orwho acts as a broker or trader for an

international transaction involving alisted chemical, tableting machine, orencapsulating machine.

Regulated seller means a retail dis-tributor (including a pharmacy or amobile retail vendor), except that theterm does not include an employee oragent of the distributor.

Regulated transaction means:(1) A distribution, receipt, sale, im-

portation, or exportation of a listed


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chemical, or an international trans-action involving shipment of a listedchemical, or if the Administrator es-tablishes a threshold amount for a spe-cific listed chemical, a thresholdamount as determined by the Adminis-trator, which includes a cumulativethreshold amount for multiple trans-actions, of a listed chemical, exceptthat such term does not include:

(i) A domestic lawful distribution inthe usual course of business betweenagents or employees of a single regu-lated person; in this context, agents or

employees means individuals under thedirect management and control of theregulated person;

(ii) A delivery of a listed chemical toor by a common or contract carrier forcarriage in the lawful and usual courseof the business of the common or con-tract carrier, or to or by a warehouse-man for storage in the lawful and usualcourse of the business of the ware-houseman, except that if the carriageor storage is in connection with thedistribution, importation, or expor-tation of a listed chemical to a thirdperson, this paragraph does not relievea distributor, importer, or exporterfrom compliance with parts 1309, 1310,

1313, and 1315 of this chapter;(iii) Any category of transaction or

any category of transaction for a spe-cific listed chemical or chemicals spec-ified by regulation of the Adminis-trator as excluded from this definitionas unnecessary for enforcement of theAct;

(iv) Any transaction in a listed chem-ical that is contained in a drug otherthan a scheduled listed chemical prod-uct that may be marketed or distrib-uted lawfully in the United Statesunder the Federal Food, Drug, and Cos-metic Act, subject to paragraph (1)(v)of this definition, unless

(A) The Administrator has deter-

mined pursuant to the criteria in 1310.10 of this chapter that the drug orgroup of drugs is being diverted to ob-tain the listed chemical for use in theillicit production of a controlled sub-stance; and

(B) The quantity of the listed chem-ical contained in the drug included inthe transaction or multiple trans-actions equals or exceeds the thresholdestablished for that chemical;

(v) Any transaction in a scheduledlisted chemical product that is a saleat retail by a regulated seller or a dis-tributor required to submit reportsunder 1310.03(c) of this chapter; or

(vi) Any transaction in a chemicalmixture designated in 1310.12 and1310.13 of this chapter that the Admin-istrator has exempted from regulation.

(2) A distribution, importation, or ex-portation of a tableting machine or en-capsulating machine except that suchterm does not include a domestic law-ful distribution in the usual course ofbusiness between agents and employeesof a single regulated person; in thiscontext, agents or employees means in-dividuals under the direct managementand control of the regulated person.

Retail distributor means a grocerystore, general merchandise store, drugstore, or other entity or person whoseactivities as a distributor relating todrug products containingpseudoephedrine or phenylpropanola-mine are limited almost exclusively tosales for personal use, both in numberof sales and volume of sales, either di-rectly to walk-in customers or in face-to-face transactions by direct sales.

Also for the purposes of this paragraph,a grocery store is an entity withinStandard Industrial Classification(SIC) code 5411, a general merchandisestore is an entity within SIC codes5300 through 5399 and 5499, and a drugstore is an entity within SIC code5912.

Scheduled listed chemical productmeans:

(1) A product that contains ephed-rine, pseudoephedrine, or phenyl-propanolamine and may be marketedor distributed lawfully in the UnitedStates under the Federal Food, Drug,and Cosmetic Act as a nonprescriptiondrug. Ephedrine, pseudoephedrine, and

phenylpropanolamine include theirsalts, optical isomers, and salts of opti-cal isomers.

(2) Scheduled listed chemical productdoes not include any product that is acontrolled substance under part 1308 ofthis chapter. In the absence of suchscheduling by the Attorney General, achemical specified in paragraph (1) ofthis definition may not be consideredto be a controlled substance.


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(3) Contains a public key that cor-responds to a private key under thesole control of the certificate holder;

(4) Identifies the operational period;and

(5) Contains a serial number and isdigitally signed by the certification au-thority issuing it.

Digital signature means a record cre-ated when a file is algorithmicallytransformed into a fixed length digestthat is then encrypted using an asym-metric cryptographic private key asso-ciated with a digital certificate. The

combination of the encryption and al-gorithm transformation ensure thatthe signers identity and the integrityof the file can be confirmed.

Digitally sign means to affix a digitalsignature to a data file.

Electronic prescription means a pre-scription that is generated on an elec-tronic application and transmitted asan electronic data file.

Electronic prescription application pro-vider means an entity that develops ormarkets electronic prescription soft-ware either as a stand-alone applica-tion or as a module in an electronichealth record application.

Electronic signature means a method

of signing an electronic message thatidentifies a particular person as thesource of the message and indicates thepersons approval of the informationcontained in the message.

False match rate means the rate atwhich an impostors biometric is false-ly accepted as being that of an author-ized user. It is one of the statisticsused to measure biometric performancewhen operating in the verification orauthentication task. The false matchrate is similar to the false accept (oracceptance) rate.

False non-match rate means the rateat which a genuine users biometric isfalsely rejected when the users bio-

metric data fail to match the enrolleddata for the user. It is one of the statis-tics used to measure biometric per-formance when operating in theverification or authentication task.The false match rate is similar to thefalse reject (or rejection) rate, exceptthat it does not include the rate atwhich a biometric system fails to ac-quire a biometric sample from a gen-uine user.

FIPS means Federal InformationProcessing Standards. These Federalstandards, as incorporated by referencein 1311.08 of this chapter, prescribespecific performance requirements,practices, formats, communicationsprotocols, etc., for hardware, software,data, etc.

FIPS 1402, as incorporated by ref-erence in 1311.08 of this chapter,means the National Institute of Stand-ards and Technology publication enti-tled Security Requirements for Cryp-tographic Modules, a Federal stand-

ard for security requirements for cryp-tographic modules.

FIPS 1802, as incorporated by ref-erence in 1311.08 of this chapter,means the National Institute of Stand-ards and Technology publication enti-tled Secure Hash Standard, a Fed-eral secure hash standard.

FIPS 1803, as incorporated by ref-erence in 1311.08 of this chapter,means the National Institute of Stand-ards and Technology publication enti-tled Secure Hash Standard (SHS), aFederal secure hash standard.

FIPS 1862, as incorporated by ref-erence in 1311.08 of this chapter,means the National Institute of Stand-

ards and Technology publication enti-tled Digital Signature Standard, aFederal standard for applications usedto generate and rely upon digital signa-tures.

FIPS 1863, as incorporated by ref-erence in 1311.08 of this chapter,means the National Institute of Stand-ards and Technology publication enti-tled Digital Signature Standard(DSS), a Federal standard for applica-tions used to generate and rely upondigital signatures.

Hard token means a cryptographickey stored on a special hardware device(e.g., a PDA, cell phone, smart card,USB drive, one-time password device)

rather than on a general purpose com-puter.

Identity proofing means the process bywhich a credential service provider orcertification authority validates suffi-cient information to uniquely identifya person.

Installed electronic prescription applica-tion means software that is used to cre-ate electronic prescriptions and that isinstalled on a practitioners computers


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21 CFR Ch. II (4114 Edition) 1300.03

and servers, where access and recordsare controlled by the practitioner.

Installed pharmacy application meanssoftware that is used to process pre-scription information and that is in-stalled on a pharmacys computers orservers and is controlled by the phar-macy.

Intermediary means any technologysystem that receives and transmits anelectronic prescription between thepractitioner and pharmacy.

Key pair means two mathematically

related keys having the propertiesthat:

(1) One key can be used to encrypt amessage that can only be decryptedusing the other key; and

(2) Even knowing one key, it iscomputationally infeasible to discoverthe other key.

NIST means the National Institute ofStandards and Technology.

NIST SP 800631, as incorporated byreference in 1311.08 of this chapter,means the National Institute of Stand-ards and Technology publication enti-tled Electronic Authentication Guide-line, a Federal standard for electronicauthentication.

NIST SP 800761, as incorporated byreference in 1311.08 of this chapter,means the National Institute of Stand-ards and Technology publication enti-tled Biometric Data Specification forPersonal Identity Verification, a Fed-eral standard for biometric data speci-fications for personal identityverification.

Operating point means a point chosenon a receiver operating characteristic(ROC) curve for a specific algorithm atwhich the biometric system is set tofunction. It is defined by its cor-responding coordinatesa false matchrate and a false non-match rate. AnROC curve shows graphically the trade-

off between the principal two types oferrors (false match rate and false non-match rate) of a biometric system byplotting the performance of a specificalgorithm on a specific set of data.

Paper prescription means a prescrip-tion created on paper or computer gen-erated to be printed or transmitted viafacsimile that meets the requirementsof part 1306 of this chapter including amanual signature.

Password means a secret, typically acharacter string (letters, numbers, andother symbols), that a person memo-rizes and uses to authenticate his iden-tity.

PDA means a Personal Digital Assist-ant, a handheld computer used to man-age contacts, appointments, and tasks.

Pharmacy application provider meansan entity that develops or marketssoftware that manages the receipt andprocessing of electronic prescriptions.

Private key means the key of a key

pair that is used to create a digital sig-nature.

Public key means the key of a keypair that is used to verify a digital sig-nature. The public key is made avail-able to anyone who will receivedigitally signed messages from theholder of the key pair.

Public Key Infrastructure (PKI) meansa structure under which a certificationauthority verifies the identity of appli-cants; issues, renews, and revokes dig-ital certificates; maintains a registryof public keys; and maintains an up-to-date certificate revocation list.

Readily retrievable means that certainrecords are kept by automatic data

processing applications or other elec-tronic or mechanized recordkeepingsystems in such a manner that theycan be separated out from all otherrecords in a reasonable time and/orrecords are kept on which certainitems are asterisked, redlined, or insome other manner visually identifi-able apart from other items appearingon the records.

SAS 70 Audit means a third-partyaudit of a technology provider thatmeets the American Institute of Cer-tified Public Accountants (AICPA)Statement of Auditing Standards(SAS) 70 criteria.

Signing function means any keystroke

or other action used to indicate thatthe practitioner has authorized fortransmission and dispensing a con-trolled substance prescription. Thesigning function may occur simulta-neously with or after the completion ofthe two-factor authentication protocolthat meets the requirements of part1311 of this chapter. The signing func-tion may have different names (e.g.,approve, sign, transmit), but it serves


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as the practitioners final authoriza-tion that he intends to issue the pre-scription for a legitimate medical rea-son in the normal course of his profes-sional practice.

SysTrust means a professional serviceperformed by a qualified certified pub-lic accountant to evaluate one or moreaspects of electronic systems.

Third-party audit means an inde-pendent review and examination ofrecords and activities to assess the ade-quacy of system controls, to ensurecompliance with established policies

and operational procedures, and to rec-ommend necessary changes in controls,policies, or procedures.

Token means something a person pos-sesses and controls (typically a key orpassword) used to authenticate the per-sons identity.

Trusted agent means an entity au-thorized to act as a representative of acertification authority or credentialservice provider in confirming practi-tioner identification during the enroll-ment process.

Valid prescription means a prescrip-tion that is issued for a legitimatemedical purpose by an individual prac-titioner licensed by law to administerand prescribe the drugs concerned andacting in the usual course of the prac-titioners professional practice.

WebTrust means a professional serv-ice performed by a qualified certifiedpublic accountant to evaluate one ormore aspects of Web sites.

[75 FR 16304, Mar. 31, 2010]

1300.04 Definitions relating to thedispensing of controlled substancesby means of the Internet.

(a) Any term not defined in this partor elsewhere in this chapter shall havethe definition set forth in sections 102and 309 of the Act (21 U.S.C. 802, 829).

(b) The term covering practitionermeans, with respect to a patient, apractitioner who conducts a medicalevaluation (other than an in-personmedical evaluation) at the request of apractitioner who:

(1) Has conducted at least one in-per-son medical evaluation of the patientor an evaluation of the patient throughthe practice of telemedicine, withinthe previous 24 months; and

(2) Is temporarily unavailable to con-duct the evaluation of the patient.

(c) The term deliver, distribute, or dis-pense by means of the Internet refers, re-spectively, to any delivery, distribu-tion, or dispensing of a controlled sub-stance that is caused or facilitated bymeans of the Internet.

(d) The term filling new prescriptionsfor controlled substances in Schedule III,IV, or V means filling a prescription foran individual for a controlled sub-stance in Schedule III, IV, or V, if:

(1) The pharmacy dispensing thatprescription has previously dispensedto the patient a controlled substanceother than by means of the Internetand pursuant to the valid prescriptionof a practitioner that meets the appli-cable requirements of subsections (b)and (c) of section 309 of the Act (21U.S.C. 829) and 1306.21 and 1306.22 ofthis chapter (for purposes of this defi-nition, such a prescription shall be re-ferred to as the original prescrip-tion);

(2) The pharmacy contacts the prac-titioner who issued the original pre-scription at the request of that indi-vidual to determine whether the prac-

titioner will authorize the issuance of anew prescription for that individual forthe controlled substance described inparagraph (d)(1) of this section (i.e., thesame controlled substance as describedin paragraph (d)(1)); and

(3) The practitioner, acting in theusual course of professional practice,determines there is a legitimate med-ical purpose for the issuance of the newprescription.

(e) The term homepage means theopening or main page or screen of theWeb site of an online pharmacy that isviewable on the Internet.

(f) The term in-person medical evalua-tion means a medical evaluation that is

conducted with the patient in the phys-ical presence of the practitioner, with-out regard to whether portions of theevaluation are conducted by otherhealth professionals. Nothing in thisparagraph shall be construed to implythat one in-person medical evaluationdemonstrates that a prescription hasbeen issued for a legitimate medicalpurpose within the usual course of pro-fessional practice.


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21 CFR Ch. II (4114 Edition) 1300.04

(g) The term Internet means collec-tively the myriad of computer andtelecommunications facilities, includ-ing equipment and operating software,which comprise the interconnectedworldwide network of networks thatemploy the Transmission Control Pro-tocol/Internet Protocol, or any prede-cessor or successor protocol to suchprotocol, to communicate informationof all kinds by wire or radio.

(h) The term online pharmacy means aperson, entity, or Internet site, wheth-er in the United States or abroad, that

knowingly or intentionally delivers,distributes, or dispenses, or offers orattempts to deliver, distribute, or dis-pense, a controlled substance by meansof the Internet. The term includes, butis not limited to, a pharmacy that hasobtained a modification of its registra-tion pursuant to 1301.13 and 1301.19 ofthis chapter that currently authorizesit to dispense controlled substances bymeans of the Internet, regardless ofwhether the pharmacy is currently dis-pensing controlled substances bymeans of the Internet. The term doesnot include:

(1) Manufacturers or distributors reg-istered under subsection (a), (b), (d), or

(e) of section 303 of the Act (21 U.S.C.823(a), (b), (d), or (e)) (1301.13 of thischapter) who do not dispense con-trolled substances to an unregisteredindividual or entity;

(2) Nonpharmacy practitioners whoare registered under section 303(f) ofthe Act (21 U.S.C. 823(f)) (1301.13 ofthis chapter) and whose activities areauthorized by that registration;

(3) Any hospital or other medical fa-cility that is operated by an agency ofthe United States (including the ArmedForces), provided such hospital orother facility is registered under sec-tion 303(f) of the Act (21 U.S.C. 823(f))( 1301.13 of this chapter);

(4) A health care facility owned oroperated by an Indian tribe or tribalorganization, only to the extent suchfacility is carrying out a contract orcompact under the Indian Self-Deter-mination and Education AssistanceAct;

(5) Any agent or employee of any hos-pital or facility referred to in para-graph (h)(3) or (h)(4) of this section,provided such agent or employee is

lawfully acting in the usual course ofbusiness or employment, and withinthe scope of the official duties of suchagent or employee, with such hospitalor facility, and, with respect to agentsor employees of health care facilitiesspecified in paragraph (h)(4) of this sec-tion, only to the extent such individ-uals are furnishing services pursuantto the contracts or compacts describedin such paragraph;

(6) Mere advertisements that do notattempt to facilitate an actual trans-action involving a controlled sub-

stance;(7) A person, entity, or Internet site

that is not in the United States anddoes not facilitate the delivery, dis-tribution, or dispensing of a controlledsubstance by means of the Internet toany person in the United States;

(8) A pharmacy registered under sec-tion 303(f) of the Act (21 U.S.C. 823(f))( 1301.13 of this chapter) whose dis-pensing of controlled substances viathe Internet consists solely of:

(i) Refilling prescriptions for con-trolled substances in Schedule III, IV,or V, as defined in paragraph (k) of thissection; or

(ii) Filling new prescriptions for con-

trolled substances in Schedule III, IV,or V, as defined in paragraph (d) of thissection;

(9)(i) Any registered pharmacy whosedelivery, distribution, or dispensing ofcontrolled substances by means of theInternet consists solely of filling pre-scriptions that were electronically pre-scribed in a manner authorized by thischapter and otherwise in compliancewith the Act.

(ii) A registered pharmacy will bedeemed to meet this exception if, inview of all of its activities other thanthose referred to in paragraph (h)(9)(i)of this section, it would fall outside thedefinition of an online pharmacy; or

(10)(i) Any registered pharmacywhose delivery, distribution, or dis-pensing of controlled substances bymeans of the Internet consists solely ofthe transmission of prescription infor-mation between a pharmacy and anautomated dispensing system locatedin a long term care facility when theregistration of the automated dis-pensing system is held by that phar-macy as described in 1301.17 and


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1301.27 and the pharmacy is otherwisecomplying with this chapter.

(ii) A registered pharmacy will bedeemed to meet this exception if, inview of all of its activities other thanthose referred to in paragraph (h)(10)(i)of this section, it would fall outside thedefinition of an online pharmacy.

(i) Effective January 15, 2010, theterm practice of telemedicine means thepractice of medicine in accordancewith applicable Federal and State lawsby a practitioner (other than a phar-macist) who is at a location remote

from the patient and is communicatingwith the patient, or health care profes-sional who is treating the patient,using a telecommunications system re-ferred to in section 1834(m) of the So-cial Security Act (42 U.S.C. 1395m(m)),which practice falls within a categorylisted in the following paragraphs (i)(1)through (7):

(1) Treatment in a hospital or clinic.The practice of telemedicine is beingconducted while the patient is beingtreated by, and physically located in, ahospital or clinic registered under sec-tion 303(f) of the Act (21 U.S.C. 823(f))by a practitioner acting in the usualcourse of professional practice, who is

acting in accordance with applicableState law, and who is registered undersection 303(f) of the Act (21 U.S.C.823(f)) in the State in which the patientis located, unless the practitioner:

(i) Is exempted from such registra-tion in all States under section 302(d)of the Act (21 U.S.C. 822(d); or

(ii) Is an employee or contractor ofthe Department of Veterans Affairswho is acting in the scope of such em-ployment or contract, and registeredunder section 303(f) of the Act (21U.S.C. 823(f)) in any State or is uti-lizing the registration of a hospital orclinic operated by the Department ofVeterans Affairs registered under sec-

tion 303(f);(2) Treatment in the physical presence

of a practitioner. The practice of tele-medicine is being conducted while thepatient is being treated by, and in thephysical presence of, a practitioneracting in the usual course of profes-sional practice, who is acting in ac-cordance with applicable State law,and who is registered under section303(f) of the Act (21 U.S.C. 823(f)) in the

State in which the patient is located,unless the practitioner:

(i) Is exempted from such registra-tion in all States under section 302(d)of the Act (21 U.S.C. 822(d)); or

(ii) Is an employee or contractor ofthe Department of Veterans Affairswho is acting in the scope of such em-ployment or contract, and registeredunder section 303(f) of the Act (21U.S.C. 823(f)) in any State or is usingthe registration of a hospital or clinicoperated by the Department of Vet-erans Affairs registered under section

303(f);(3) Indian Health Service or tribal orga-

nization. The practice of telemedicineis being conducted by a practitionerwho is an employee or contractor ofthe Indian Health Service, or is work-ing for an Indian tribe or tribal organi-zation under its contract or compactwith the Indian Health Service underthe Indian Self-Determination andEducation Assistance Act; who is act-ing within the scope of the employ-ment, contract, or compact; and who isdesignated as an Internet Eligible Con-trolled Substances Provider by the Sec-retary of Health and Human Servicesunder section 311(g)(2) of the Act (21

U.S.C. 831(g)(2));(4) Public health emergency declared by

the Secretary of Health and Human Serv-ices. The practice of telemedicine isbeing conducted during a public healthemergency declared by the Secretaryof Health and Human Services undersection 319 of the Public Health ServiceAct (42 U.S.C. 247d), and involves pa-tients located in such areas, and suchcontrolled substances, as the Secretaryof Health and Human Services, withthe concurrence of the Administrator,designates, provided that such designa-tion shall not be subject to the proce-dures prescribed by the AdministrativeProcedure Act (5 U.S.C. 551559 and 701

706);(5) Special registration. The practice of

telemedicine is being conducted by apractitioner who has obtained from theAdministrator a special registrationunder section 311(h) of the Act (21U.S.C. 831(h));

(6) Department of Veterans Affairs med-ical emergency. The practice of tele-medicine is being conducted:

(i) In a medical emergency situation:


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21 CFR Ch. II (4114 Edition) 1300.04

(A) That prevents the patient frombeing in the physical presence of apractitioner registered under section303(f) of the Act (21 U.S.C. 823(f)) who isan employee or contractor of the Vet-erans Health Administration acting inthe usual course of business and em-ployment and within the scope of theofficial duties or contract of that em-ployee or contractor;

(B) That prevents the patient frombeing physically present at a hospitalor clinic operated by the Departmentof Veterans Affairs registered under

section 303(f) of the Act (21 U.S.C.823(f));

(C) During which the primary carepractitioner of the patient or a practi-tioner otherwise practicing telemedi-cine within the meaning of this para-graph is unable to provide care or con-sultation; and

(D) That requires immediate inter-vention by a health care practitionerusing controlled substances to preventwhat the practitioner reasonably be-lieves in good faith will be imminentand serious clinical consequences, suchas further injury or death; and

(ii) By a practitioner that:(A) Is an employee or contractor of

the Veterans Health Administrationacting within the scope of that employ-ment or contract;

(B) Is registered under section 303(f)of the Act (21 U.S.C. 823(f)) in any Stateor is utilizing the registration of a hos-pital or clinic operated by the Depart-ment of Veterans Affairs registeredunder section 303(f); and

(C) Issues a controlled substance pre-scription in this emergency contextthat is limited to a maximum of a five-day supply which may not be extendedor refilled; or

(7) Other circumstances specified by reg-ulation. The practice of telemedicine isbeing conducted under any other cir-

cumstances that the Administratorand the Secretary of Health andHuman Services have jointly, by regu-lation, determined to be consistentwith effective controls against diver-sion and otherwise consistent with thepublic health and safety.

(j) Temporary definition of practice oftelemedicine. Prior to January 15, 2010,or as otherwise specified by regulationprior to that date, instead of the defini-

tion in paragraph (i), the term practice

of telemedicine means the practice of

medicine in accordance with applicable

Federal and State laws by a practi-

tioner (as that term is defined in sec-

tion 102 of the Act (21 U.S.C. 802))

(other than a pharmacist) who is at a

location remote from the patient and is

communicating with the patient, or

health care professional who is treat-

ing the patient, using a telecommuni-

cations system referred to in section

1834(m) of the Social Security Act (42

U.S.C. 1395m(m)), if the practitioner isusing an interactive telecommuni-

cations system that satisfies the re-

quirements of section 410.78(a)(3) of

title 42, Code of Federal Regulations.

(k) The term refilling prescriptions for

controlled substances in Schedule III, IV,

or V:

(1) Means the dispensing of a con-

trolled substance in Schedule III, IV, or

V in accordance with refill instructions

issued by a practitioner as part of a

valid prescription that meets the re-

quirements of subsections (b) and (c) of

section 309 of the Act (21 U.S.C. 829)

and 1306.21 and 1306.22 of this chapter,

as appropriate; and(2) Does not include the issuance of a

new prescription to an individual for a

controlled substance that individual

was previously prescribed.

(l)(1) The term valid prescription

means a prescription that is issued for

a legitimate medical purpose in the

usual course of professional practice

by:

(i) A practitioner who has conducted

at least one in-person medical evalua-

tion of the patient; or

(ii) A covering practitioner.

(2) Nothing in this paragraph (l) shall

be construed to imply that one in-per-

son medical evaluation demonstrates

that a prescription has been issued for

a legitimate medical purpose within

the usual course of professional prac-

tice.

[74 FR 15619, Apr. 6, 2009]


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21 CFR Ch. II (4114 Edition) 1301.01

GENERAL INFORMATION

1301.01 Scope of this part 1301.

Procedures governing the registra-tion of manufacturers, distributors,dispensers, importers, and exporters ofcontrolled substances pursuant to sec-tions 301304 and 10071008 of the Act (21U.S.C. 821824 and 957958) are set forthgenerally by those sections and specifi-cally by the sections of this part.

[62 FR 13945, Mar. 24, 1997]

1301.02 Definitions.

Any term used in this part shall havethe definition set forth in section 102 ofthe Act (21 U.S.C. 802) or part 1300 ofthis chapter.

[62 FR 13945, Mar. 24, 1997]

1301.03 Information; special instruc-tions.

Information regarding proceduresunder these rules and instructionssupplementing these rules will be fur-nished upon request by writing to theRegistration Section, Drug Enforce-ment Administration. See the Table ofDEA Mailing Addresses in 1321.01 ofthis chapter for the current mailing ad-

dress.

[75 FR 10676, Mar. 9, 2010]

REGISTRATION

1301.11 Persons required to register;requirement of modification of reg-istration authorizing activity as anonline pharmacy.

(a) Every person who manufactures,distributes, dispenses, imports, or ex-ports any controlled substance or whoproposes to engage in the manufacture,distribution, dispensing, importationor exportation of any controlled sub-stance shall obtain a registration un-less exempted by law or pursuant to

1301.22 through 1301.26. Except as pro-vided in paragraph (b) of this section,only persons actually engaged in suchactivities are required to obtain a reg-istration; related or affiliated personswho are not engaged in such activitiesare not required to be registered. (Forexample, a stockholder or parent cor-poration of a corporation manufac-turing controlled substances is not re-quired to obtain a registration.)

(b) As provided in sections 303(f) and401(h) of the Act (21 U.S.C. 823(f) and841(h)), it is unlawful for any personwho falls within the definition of on-line pharmacy (as set forth in section102(52) of the Act (21 U.S.C. 802(52)) and 1300.04(h) of this chapter) to deliver,distribute, or dispense a controlled sub-stance by means of the Internet if suchperson is not validly registered with amodification of such registration au-thorizing such activity (unless suchperson is exempt from such modifiedregistration requirement under the Act

or this chapter). The Act further pro-vides that the Administrator may onlyissue such modification of registrationto a person who is registered as a phar-macy under section 303(f) of the Act (21U.S.C. 823(f)). Accordingly, any phar-macy registered pursuant to 1301.13 ofthis part that falls within the defini-tion of an online pharmacy and pro-poses to dispense controlled substancesby means of the Internet must obtain amodification of its registration author-izing such activity following the sub-mission of an application in accordancewith 1301.19 of this part. This require-ment does not apply to a registeredpharmacy that does not fall within thedefinition of an online pharmacy setforth in 1300.04(h). Under the Act, per-sons other than registered pharmaciesare not eligible to obtain such a modi-fication of registration but remain lia-ble under section 401(h) of the Act (21U.S.C. 841(h)) if they deliver, dis-tribute, or dispense a controlled sub-stance while acting as an online phar-macy without being validly registeredwith a modification authorizing suchactivity.

[74 FR 15621, Apr. 6, 2009]

1301.12 Separate registrations forseparate locations.

(a) A separate registration is re-quired for each principal place of busi-ness or professional practice at onegeneral physical location where con-trolled substances are manufactured,distributed, imported, exported, or dis-pensed by a person.

(b) The following locations shall bedeemed not to be places where con-trolled substances are manufactured,distributed, or dispensed:


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(1) A warehouse where controlledsubstances are stored by or on behalf ofa registered person, unless such sub-stances are distributed directly fromsuch warehouse to registered locationsother than the registered location fromwhich the substances were delivered orto persons not required to register byvirtue of subsection 302(c)(2) or sub-section 1007(b)(1)(B) of the Act (21U.S.C. 822(c)(2) or 957(b)(1)(B));

(2) An office used by agents of a reg-istrant where sales of controlled sub-stances are solicited, made, or super-

vised but which neither contains suchsubstances (other than substances fordisplay purposes or lawful distributionas samples only) nor serves as a dis-tribution point for filling sales orders;and

(3) An office used by a practitioner(who is registered at another locationin the same State or jurisdiction of theUnited States) where controlled sub-stances are prescribed but neither ad-ministered nor otherwise dispensed asa regular part of the professional prac-tice of the practitioner at such office,and where no supplies of controlledsubstances are maintained.

(4) A freight forwarding facility, as

defined in 1300.01 of this part, providedthat the distributing registrant oper-ating the facility has submitted writ-ten notice of intent to operate the fa-cility by registered mail, return re-ceipt requested (or other suitablemeans of documented delivery) andsuch notice has been approved. The no-tice shall be submitted to the SpecialAgent in Charge of the Administra-tions offices in both the area in whichthe facility is located and each area inwhich the distributing registrant main-tains a registered location that willtransfer controlled substances throughthe facility. The notice shall detail theregistered locations that will utilize

the facility, the location of the facil-ity, the hours of operation, the indi-vidual(s) responsible for the controlledsubstances, the security and record-keeping procedures that will be em-ployed, and whether controlled sub-stances returns will be processedthrough the facility. The notice mustalso detail what state licensing re-quirements apply to the facility andthe registrants actions to comply with

any such requirements. The SpecialAgent in Charge of the DEA Office inthe area where the freight forwardingfacility will be operated will providewritten notice of approval or dis-approval to the person within thirtydays after confirmed receipt of the no-tice. Registrants that are currently op-erating freight forwarding facilitiesunder a memorandum of understandingwith the Administration must providenotice as required by this section nolater than September 18, 2000 and re-ceive written approval from the Spe-

cial Agent in Charge of the DEA Officein the area in which the freight for-warding facility is operated in order tocontinue operation of the facility.

[62 FR 13945, Mar. 24, 1997, as amended at 65FR 44678, July 19, 2000; 65 FR 45829, July 25,2000; 71 FR 69480, Dec. 1, 2006]

1301.13 Application for registration;time for application; expirationdate; registration for independentactivities; application forms, fees,contents and signature; coincidentactivities.

(a) Any person who is required to beregistered and who is not so registeredmay apply for registration at any time.

No person required to be registeredshall engage in any activity for whichregistration is required until the appli-cation for registration is granted and aCertificate of Registration is issued bythe Administrator to such person.

(b) Any person who is registered mayapply to be reregistered not more than60 days before the expiration date ofhis/her registration, except that a bulkmanufacturer of Schedule I or II con-trolled substances or an importer ofSchedule I or II controlled substancesmay apply to be reregistered no morethan 120 days before the expirationdate of their registration.

(c) At the time a manufacturer, dis-

tributor, reverse distributor, re-searcher, analytical lab, importer, ex-porter or narcotic treatment programis first registered, that business activ-ity shall be assigned to one of twelvegroups, which shall correspond to themonths of the year. The expirationdate of the registrations of all reg-istrants within any group will be thelast date of the month designated forthat group. In assigning any of these


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21 CFR Ch. II (4114 Edition) 1301.13

business activities to a group, the Ad-ministration may select a group theexpiration date of which is less thanone year from the date such businessactivity was registered. If the businessactivity is assigned to a group whichhas an expiration date less than threemonths from the date of which thebusiness activity is registered, the reg-istration shall not expire until oneyear from that expiration date; in allother cases, the registration shall ex-pire on the expiration date followingthe date on which the business activity

is registered.(d) At the time a retail pharmacy,

hospital/clinic, practitioner or teach-ing institution is first registered, thatbusiness activity shall be assigned toone of twelve groups, which shall cor-respond to the months of the year. Theexpiration date of the registrations ofall registrants within any group will bethe last day of the month designatedfor that group. In assigning any of theabove business activities to a group,the Administration may select a groupthe expiration date of which is not lessthan 28 months nor more than 39months from the date such business ac-tivity was registered. After the initial

registration period, the registrationshall expire 36 months from the initialexpiration date.

(e) Any person who is required to beregistered and who is not so registered,shall make application for registrationfor one of the following groups of con-trolled substances activities, which are

deemed to be independent of eachother. Application for each registrationshall be made on the indicated form,and shall be accompanied by the indi-cated fee. Fee payments shall be madein the form of a personal, certified, orcashiers check or money order madepayable to the Drug Enforcement Ad-ministration. The application fees arenot refundable. Any person, when reg-istered to engage in the activities de-scribed in each subparagraph in thisparagraph, shall be authorized to en-gage in the coincident activities de-

scribed without obtaining a registra-tion to engage in such coincident ac-tivities, provided that, unless specifi-cally exempted, he/she complies withall requirements and duties prescribedby law for persons registered to engagein such coincident activities. Any per-son who engages in more than onegroup of independent activities shallobtain a separate registration for eachgroup of activities, except as providedin this paragraph under coincident ac-tivities. A single registration to engagein any group of independent activitieslisted below may include one or morecontrolled substances listed in theschedules authorized in that group of

independent activities. A person reg-istered to conduct research with con-trolled substances listed in Schedule Imay conduct research with any sub-stances listed in Schedule I for whichhe/she has filed and had approved a re-search protocol.

(1)

Business activityControlled sub-

stancesDEA Application

forms

Applicationfee($)

Registrationperiod(years)

Coincident activities allowed

(i) Manufacturing Schedules IV ... New225 Re-newal225a.

$3,047 1 Schedules IV: May distribute that sub-stance or class for which registrationwas issued; may not distribute ordispose of any substance or classfor which not registered. SchedulesIIV: Except a person registered todispose of any controlled substance

may conduct chemical analysis andpreclinical research (including qualitycontrol analysis) with substances list-ed in those schedules for which au-thorization as a mfg. was issued.

(ii) Distributing .... Schedules IV ... New225 Re-newal225a.

1,523 1

(iii) Reverse dis-tributing.

Schedules IV ... New225 Re-newal225a.

1,523 1


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Dru